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SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty

NCT05919888 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-10

Study results available
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Summary

Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the deep tissues at the end of the surgery may prevent infections from developing in the future.

Conditions

  • Surgery
  • Surgical Site Infection
  • Cutibacterium Acnes
  • Prosthetic-joint Infection

Interventions

DRUG

Povidone-Iodine

Applied to skin incision.

DEVICE

SURGX Wound Gel

Applied to skin incision.

Sponsors & Collaborators

  • Next Science LLC

    collaborator UNKNOWN

  • St. Louis University

    lead OTHER

Principal Investigators

  • Randall Otto, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2023-11-14
Completion
2023-11-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919888 on ClinicalTrials.gov